Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00941798
First received: July 14, 2009
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.


Condition Intervention Phase
Asthma
Drug: QMF149 Twisthaler®
Drug: Mometasone Twisthaler®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time to First Serious Asthma Exacerbation [ Time Frame: Up to 21 months ] [ Designated as safety issue: No ]
    Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.


Secondary Outcome Measures:
  • Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. [ Time Frame: up to 21 months ] [ Designated as safety issue: No ]
    The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.

  • Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids [ Time Frame: Up to 21 months ] [ Designated as safety issue: No ]
    Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months).

  • Number of Patients With at Least One Asthma Worsening Post-baseline [ Time Frame: Up to 21 months ] [ Designated as safety issue: No ]
    The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) >= 20% from mean baseline on >= 3 consecutive days, nighttime symptom score >= 2 on >= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) >=20% from baseline at evening visits, daytime symptom score of 3 or 4 on >= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use >= 8 puffs on >= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms).

  • Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ] [ Designated as safety issue: No ]
    Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

  • Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose ] [ Designated as safety issue: No ]
    Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

  • Change From Baseline in Forced Vital Capacity (FVC) at Final Visit [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose ] [ Designated as safety issue: No ]
    Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

  • Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ] [ Designated as safety issue: No ]

    PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits.

    Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient.


  • Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ] [ Designated as safety issue: No ]
    Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.

  • Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ] [ Designated as safety issue: No ]

    Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment.

    Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.


  • Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ] [ Designated as safety issue: No ]
    24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.

  • Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ] [ Designated as safety issue: No ]

    The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control.

    Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.



Enrollment: 2283
Study Start Date: July 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QMF149 Twisthaler® 500/400
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
Drug: QMF149 Twisthaler®
Once daily via multi-dose dry-powder inhaler
Active Comparator: Mometasone Twisthaler®
Mometasone Twisthaler®, 400 µg QD
Drug: Mometasone Twisthaler®
Once daily via multi-dose dry-powder inhaler

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a documented diagnosis of persistent asthma and who were currently treated with or qualified for treatment with both ICS and long-acting beta2-agonist (LABA) combination
  • Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥ 12% or ≥ 200 mLs within 30 minutes after administration of short-acting beta2-agonist (SABA)
  • Patients with an FEV1 ≥ 50% of predicted normal

Exclusion Criteria:

  • Patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD)
  • Patients who had an asthma attack/exacerbation requiring hospitalization/emergency room visit or respiratory tract infection within 1 month prior to randomization
  • Patients who had ever required ventilator support for respiratory failure
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Patients with concomitant pulmonary disease
  • Patients with certain cardiovascular co-morbid conditions
  • Patients with any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941798

  Hide Study Locations
Locations
United States, Alabama
Novartis Investigator Site
Birmingham, Alabama, United States, 35209
United States, California
Novartis Investigator Site
Buena Park, California, United States, 90620
Novartis Investigator Site
Encinitas, California, United States, 92024
Novartis Investigator Site
Fullerton, California, United States, 92835
Novartis Investigator Site
Long Beach, California, United States, 90808
Novartis Investigator Site
Los Angeles, California, United States, 90025
Novartis Investigator Site
Orange, California, United States, 92868
Novartis Investigator Site
Riverside, California, United States, 92506
Novartis Investigator Site
San Diego, California, United States, 92123
Novartis Investigator Site
San Jose, California, United States, 95117
Novartis Investigator Site
San Mateo, California, United States, 94401
Novartis Investigator Site
Vista, California, United States, 92083
Novartis Investigator Site
Walnut Creek, California, United States, 94598
United States, Colorado
Novartis Investigator Site
Denver, Colorado, United States, 80230
Novartis Investigator Site
Engelwood, Colorado, United States, 80112
Novartis Investigator Site
Lakewood, Colorado, United States, 80401
Novartis Investigator Site
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Novartis Investigator Site
Clearwater, Florida, United States, 33756
Novartis Investigator Site
Clearwater, Florida, United States, 33765
Novartis Investigative Site
Miami, Florida, United States, 33136
Novartis Investigative Site
Miami, Florida, United States, 33157
Novartis Investigator Site
Port Charlotte, Florida, United States, 33952
Novartis Investigator Site
Sarasota, Florida, United States, 34233
Novartis Investigative Site
South Miami, Florida, United States, 33143
Novartis Investigator Site
Tampa, Florida, United States, 33603
United States, Georgia
Novartis Investigative Site
Albany, Georgia, United States, 31707
Novartis Investigative Site
Columbus, Georgia, United States, 31904
Novartis Investigative Site
Savannah, Georgia, United States, 31406
United States, Idaho
Novartis Investigator Site
Couer D'Alene, Idaho, United States, 83814
United States, Illinois
Novartis Investigator Site
Chicago, Illinois, United States, 60612
Novartis Investigator Site
Normal, Illinois, United States, 61761
Novartis Investigator Site
River Forest, Illinois, United States, 60305
Novartis Investigator Site
Skokie, Illinois, United States, 60076
Novartis Investigator Site
Springfield, Illinois, United States, 62703
United States, Indiana
Novartis Investigator Site
Evansville, Indiana, United States, 47713
Novartis Investigator Site
Indianapolis, Indiana, United States, 46208
United States, Iowa
Novartis Investigator Site
Iowa City, Iowa, United States, 52240
United States, Kansas
Novartis Investigator Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Novartis Investigator Site
Owensboro, Kentucky, United States, 42301
United States, Louisiana
Novartis Investigator Site
Metarie, Louisiana, United States, 70002
United States, Maine
Novartis Investigative Site
Bangor, Maine, United States, 04401
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21236
Novartis Investigative Site
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Novartis Investigative Site
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Novartis Investigator Site
Minneapolis, Minnesota, United States, 55402
Novartis Investigator Site
Plymouth, Minnesota, United States, 55441
United States, Missouri
Novartis Investigator Site
Ozark, Missouri, United States, 65721
Novartis Investigator Site
Rolla, Missouri, United States, 65401
Novartis Investigator Site
St. Louis, Missouri, United States, 63141
Novartis Investigator Site
Warrensburg, Missouri, United States, 64093
United States, Nebraska
Novartis Investigator Site
Bellevue, Nebraska, United States, 68123
Novartis Investigator Site
Omaha, Nebraska, United States, 68130
Novartis Investigator Site
Omaha, Nebraska, United States, 68131
United States, New Jersey
Novartis Investigative Site
Brick, New Jersey, United States, 08724
Novartis Investigative Site
Cedar Knolls, New Jersey, United States, 07927
Novartis Investigative Site
Skillman, New Jersey, United States, 08558
United States, New Mexico
Novartis Investigator Site
Albuquerque, New Mexico, United States, 87108
United States, New York
Novartis Investigative Site
Mineola, New York, United States, 11501
Novartis Investigative Site
Newburgh, New York, United States, 12550
Novartis Investigative Site
Rochester, New York, United States, 14618-2638
United States, North Carolina
Novartis Investigative Site
High Point, North Carolina, United States, 27262
Novartis Investigative site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Novartis Investigator Site
Canton, Ohio, United States, 44718
Novartis Investigator Site
Columbus, Ohio, United States, 43213
Novartis Investigator Site
Marion, Ohio, United States, 43302
Novartis Investigator Site
Sylvania, Ohio, United States, 43560
United States, Oklahoma
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73104
Novartis Investigator Site
Oklahoma City, Oklahoma, United States, 73112
Novartis Investigator Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Novartis Investigator Site
Portland, Oregon, United States, 97213
United States, Pennsylvania
Novartis Investigative Site
Blue Bell, Pennsylvania, United States, 19422
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19115
Novartis Investigative site
Philadelphia, Pennsylvania, United States, 19140
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15221
United States, Rhode Island
Novartis Investigator Site
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Novartis Investigative Site
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Novartis Investigator Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novartis Investigator Site
Dallas, Texas, United States, 75230
Novartis Investigator Site
Dallas, Texas, United States, 75231
Novartis Investigator Site
Dickinson, Texas, United States, 77539
Novartis Investigator Site
El Paso, Texas, United States, 79925
Novartis Investigator Site
Fort Worth, Texas, United States, 76132
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigator Site
Houston, Texas, United States, 77054
Novartis Investigator Site
New Braunfels, Texas, United States, 78130
Novartis Investigator Site
San Antonio, Texas, United States, 78229
United States, Vermont
Novartis Investigative Site
South Burlington, Vermont, United States, 05403
United States, Virginia
Novartis Investigative Site
Abingdon, Virginia, United States, 24210
United States, Washington
Novartis Investigator Site
Kirkland, Washington, United States, 98034
Novartis Investigator Site
Seattle, Washington, United States, 98105
Novartis Investigator Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
Novartis Investigator Site
Milwaukee, Wisconsin, United States, 53209
Brazil
Novartis Investigative Site
Belo Horizonte, Brazil
Novartis Investigative Site
Florianopolis, Brazil
Novartis Investigative Site
Porto Alegre, Brazil
Novartis Investigative Site
Rio de Janeiro, Brazil
Novartis Investigative Site
Salvador, Brazil
Novartis Investigative Site
Sao Paulo, Brazil
Colombia
Novartis Investigative Site
Barranquilla, Colombia
Novartis Investigative Site
Bogota, Colombia
Czech Republic
Novartis Investigator Site
Boskovice, Czech Republic
Novartis Investigator Site
Breclav, Czech Republic
Novartis Investigator Site
Brno, Czech Republic
Novartis Investigator Site
Brno - Bohunice, Czech Republic
Novartis Investigator Site
Hradec Kralove, Czech Republic
Novartis Investigator Site
Jablonec nad Nisou, Czech Republic
Novartis Investigator Site
Kladno, Czech Republic
Novartis Investigator Site
Kutna Hora, Czech Republic
Novartis Investigator Site
Liberec, Czech Republic
Novartis Investigator Site
Most, Czech Republic
Novartis Investigator Site
Plzen, Czech Republic
Novartis Investigator Site
Praha, Czech Republic
Novartis Investigator Site
Tabor, Czech Republic
Novartis Investigator Site
Teplice, Czech Republic
Novartis Investigative Site
Trutnov, Czech Republic
Hungary
Novartis Investigative Site
Balassagyarmat, Hungary
Novartis Investigative Site
Debrecen, Hungary
Novartis Investigator Site
Deszk, Hungary
Novartis Investigative Site
Gyor, Hungary
Novartis Investigative Site
Mosonmagyarovar, Hungary
Novartis Investigative Site
Nyiregyhaza, Hungary
Novartis Investigative Site
Tatabanya, Hungary
Novartis Investigative Site
Torokbalint, Hungary
India
Novartis Investigator Site
Chennai, India
Novartis Investigator Site
Coimbatore, India
Novartis Investigator Site
Hyderabaad, India
Novartis Investigator Site
Indore, India
Novartis Investigator Site
Mangalore, India
Novartis Investigator Site
Mumbai, India
Novartis Investigator Site
Nagpur, India
Novartis Investigator Site
Panjim, India
Korea, Republic of
Novartis Investigative Site
Gwangju, Korea, Republic of
Novartis Investigative SIte
Seoul, Korea, Republic of
Novartis Investigator Site
Seoul, Korea, Republic of
Peru
Novartis Investigator Site
Lima, Peru
Slovakia
Novartis Investigator Site
Bardejov, Slovakia
Novartis Investigative Site
Bojnice, Slovakia
Novartis Investigator Site
Bratislava, Slovakia
Novartis Investigator Site
Kosice, Slovakia
Novartis Investigator Site
Levice, Slovakia
Novartis Investigator Site
Liptovsky Hradok, Slovakia
Novartis Investigator Site
Michalovce, Slovakia
Novartis Investigative Site
Nitra, Slovakia
Novartis Investigative Site
Surany, Slovakia
Novartis Investigator Site
Trencin, Slovakia
Novartis Investigator Site
Vrable, Slovakia
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00941798     History of Changes
Other Study ID Numbers: CQMF149A2210, EudraCT number 2009-011539-10
Study First Received: July 14, 2009
Results First Received: May 3, 2012
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Slovakia: State Institute for Drug Control
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Korea: Food and Drug Administration

Keywords provided by Novartis:
Asthma
LABA
Safety

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 22, 2014